A gentle helper in medicine and nutrition
NATURAL
INDICATIONS
>> a carbohydrate derived from nature
Constipation
Portal systemic encephalopathy
>> a gentle and effective laxative
>> the gold standard for
blood ammonia reduction
Though lactulose does not occur in nature,
it is an isomer of lactose, the natural milk
sugar, and is produced directly from
lactose. Lactulose is a disaccharide
of the simple sugars galactose and
fructose. Enzymes in the gut can split
lactose, but not lactulose.
Lactulose is a laxative that is widely used to treat
chronic constipation. It has a particularly gentle
and natural mode of action that involves prebiotic,
osmotic and peristalsis-activating effects. It has
been in regular use since the 1960s. Lactulose is
well tolerated in long-term use, even in patient
groups regarded as sensitive, such as pregnant
women, babies and people with diabetes. However,
mild side effects may occur during the first days of
treatment.
The other indication for lactulose is portal
systemic encephalopathy (PSE), also known as
hepatic encephalopathy. This is a disease state
that results from liver damage, for example in
advanced cirrhosis. The impaired liver function
allows toxic substances, including ammonia, to
accumulate in the bloodstream. Elevated blood
ammonia interferes with brain functions, causing
cognitive dysfunction and psychiatric disorders.
Lactulose is an effective agent for reducing
ammonia levels in this condition, and helps
restore normal neurological function.
HOW IT WORKS
>> bifidogenic
Enzymes in the gut can split lactose, but not lactulose. Since lactulose is not split in
the gut, and is not absorbed, it passes on to the lower part of the intestine unchanged. It
can be used as an energy source by Bifidobacteria and Lactobacilli, and promotes growth
of these bacteria — the bifidogenic effect. High counts of Bifidobacteria are considered
good for intestinal health. Beneficial effects of balanced gut flora include protection
against gut pathogens, improved digestion, “training” of the immune system,
breakdown of carcinogenic substances and biosynthesis of vitamins.
>> laxative
ADVANTAGES
Increasing the amount of live bacteria in the colon helps make the stool softer.
Also, bacteria using lactulose as their energy source produce short chain fatty acids
and lactic acid — and the resulting increase in acidity raises the osmotic pressure,
so that more water is retained in the colon. The acidity and the increase in bulk of
the colon contents both stimulate peristalsis. The results: both a real reduction in
colonic transit time and subjective ease of passing stool.
>> lowering ammonia
Fermentation of lactulose by Bifidobacteria has another beneficial effect:
it helps lower blood ammonia levels. Bifidobacteria growth helps suppress
ammonia-producing bacteria. Increased acidity ionizes ammonia (NH3) to
ammonium ions (NH4+). Since ammonium ions are not absorbed from the
intestine, this draws more ammonia from the bloodstream. The reduced
colonic transit time also means that ammonia is excreted more effectively.
>> from bifidogenic to ammonia binding
Application
Effect
Dosage
PSE
Detoxifying
High
Constipation
Laxative
Moderate
Prebiotic
Bifidogenic
Low
>> unique
Other laxatives may act by increasing bulk, directly stimulating colonic movement or by simple osmotic
effects. By promoting growth of Bifidobacteria, lactulose triggers natural responses of the intestine, with
a combination of all three mechanisms.
>> at a glance
• Good tolerability and safety profile
• Suitable for long-term use
• Gentle and natural mode of action
• Improvement of natural intestinal flora
• Not habit forming
• Minimal energy value (0.1 – 1.0 kcal/g)
• Convenient presentation forms
IN FOOD
>> healthy gut – healthy body
In today‘s fast-moving world, living and eating habits often have a negative impact on
metabolism and digestion. Improving the interaction of food, metabolism, and the immune
system, lactulose can help restore some balance.
>> a growth factor for health-promoting bacteria
Prebiotics are food ingredients that improve health and wellbeing by selectively stimulating
the growth and activity of beneficial intestinal bacteria. It has been demonstrated that
lactulose is used as an energy source by Bifidobacteria and Lactobacilli, stimulating
their growth and activity. This means lactulose can help improve the colonic flora
and stabilize a healthy mix of organisms.
>> food ingredient
The prebiotic effects of lactulose mean it can be used to improve the
contribution of diverse convenience foods to overall wellbeing.
Also, food products tailored for special age groups or
persons with special nutrition requirements can be
designed with lactulose as an ingredient.
ANIMAL FEED
>> new directions in animal nutrition
Reducing the use of antibiotics is a major issue in livestock breeding. Consumer acceptance of
contaminated products is in fast decline. There is a strong need for health-promoting and
health-maintaining feed ingredients. The positive effects of lactulose on animal gastrointestinal health
make it an attractive ingredient for the development of balanced pet food or animal feed.
PRODUCT INFORMATION
>> from API to finished products
Fresenius Kabi Austria is one of the world‘s major lactulose suppliers, with more than 40 years of experience
in its production and distribution. We manufacture and distribute lactulose in liquid and crystalline form, as
an active pharmaceutical ingredient (API) or as finished, packaged pharmaceutical products.
>> wide range of API formulations
Lactulose Liquid
Standard (67% w/v)
Special (up to 70% w/v)
Purified Lactulose Solution (50 - 55% w/w)
Lactulose Crystals (97% w/w)
MANUFACTURING
>> flexibility of final dosage forms
Our lactulose API production process runs around the clock, seven days a week. An order-related and
just-in-time production system ensures the delivery of API to our customers all over the world with
a maximum shelf life.
We have our production and filling lines side by side,
so we can make lactulose finished product seamlessly
after the bulk process. The range of dosage and presentation
forms covers PET or HDPE bottles of various sizes (100ml to
1000ml) and convenient single dose sachets for liquid (10g/15ml)
or crystalline lactulose (10g) in boxes of up to 100 single doses.
>> excellent logistics
>> top quality
Strict quality control with pharmacopeial and/or precisely validated methods for all analyses is done at all
stages from the incoming raw materials to the final products. The manufacturing process is embedded in a
comprehensive quality assurance program.
>> continual development
>> always under review
To meet the demands and need of our customers, Fresenius Kabi Austria
is constantly expanding its product portfolio. For example, although
unflavored lactulose is very popular, we also offer flavored versions.
Our quality assurance unit continually reviews all processes and documentations to safeguard compliance
with current certifications. Fulfillment of all applicable regulations is audited by local as well as international
regulatory authorities, and also by customers.
>> specifications
The production of lactulose API is in line with current Good Manufacturing
Practice (GMP/cGMP) guidelines, ISO 9001:2008, and ISO 14001:2009.
It meets the specifications of European, Japanese and US pharmacopeias.
PRODUCTION SITES
>> two plants – one mission
Fresenius Kabi Austria distributes API lactulose in liquid and crystalline
form manufactured at two productions sites in Linz, Austria, and in
Vicchio, Italy, to customers all over the world.
>> linz, austria
The lactulose production process was developed in the laboratories
in Linz and patented in 1969. A high level of automation, the electronic
batch handling system, and the environment-friendly process developed
in-house support constantly high quality and excellent flexibility of the
production process. A pharmaceutical production unit on site enables
us to process lactulose without delay into finished products.
>> vicchio, italy
The Italian plant has long experience in the manufacture of the API
lactulose liquid and crystals. The facility in Vicchio is an up-to-date
production site of the highest quality standards. With the unique and
patented process it is the only plant in Europe that manufactures
lactulose crystals to the EP specification.
BUSINESS DEVELOPMENT
>> from approval to market
An experienced and highly qualified regulatory affairs team will provide you with European or US drug
master files (USDMF, ASMF, and CEP). We also prepare common technical document (e-CTD) dossiers for
registration of pure or flavored lactulose in multi- and single-dose formats. Precise adherence to the
requirements of our customers is guaranteed.
ABOUT US
>> fresenius kabi
The international Fresenius Kabi Group runs two production sites for lactulose. In Vicchio del Mugello, Italy,
Società Chimica Mugello S.r.l. produces the APIs lactulose liquid and lactulose crystals (FDA approved). The
facility in Linz manufactures the API lactulose liquid (FDA approved), but also the APIs Hydroxyethyl Starch
(HES; FDA approved), and Sinistrin.
>> contact us
>> adding value to your product
We offer professional assistance with packaging design in order to give our lactulose product the look
of your choice. With in-house expertise, we support local marketing and medical teams in developing
appropriate materials in accordance with applicable legal requirements. Fresenius Kabi Austria‘s
own successful lactulose brand is registered in numerous countries all over the world.
Fresenius Kabi Austria GmbH
Estermannstraße 17, 4020 Linz, Austria
Fax: +43 732 7651-2330
E-mail: [email protected]
Web: www.fresenius-kabi.at
www.lactulose.eu
Or visit our partnering site at:
www.fresenius-productpartnering.com
WORLDWIDE DISTRIBUTION
>> service is our concern
Our highly motivated and competent service team
coordinates the worldwide distribution of lactulose,
helping you to deliver value across the whole supply
chain. With the aim of achieving 100% customer
satisfaction, we develop best-case solutions for our
customers throughout the world.
Issued by
S.C.M., Società Chimica Mugello, S.r.l.
A Fresenius Kabi Company
Via E. Mattei, 26
50039 Vicchio, Italy
[email protected]
www.lactulose.eu
Disclaimer: This is business-to-business information and not
intended for final consumers. Fresenius Kabi Austria GmbH/
S.C.M. do not assume any liability on statements and/or claims
on health benefits or nutritional properties on packaging and/
or advertising on finished products. This is incumbent upon the
producer and/or vender of finished products and has to be in
accordance with local regulations.
PBL02, © Società Chimica Mugello S.r.l., October 2013